Group 1 - Company Gannee Pharmaceutical (甘李药业) announced that its wholly-owned subsidiary received the clinical trial approval for the investigational drug GLR1044 injection from the National Medical Products Administration [1] - GLR1044 injection is a biosimilar to Dupilumab (达必妥®) and is indicated for the treatment of moderate to severe atopic dermatitis in adults who have inadequate control with topical prescription medications [1] - The drug can be used alone or in combination with topical corticosteroids [1] Group 2 - Atopic Dermatitis (AD) is a common chronic inflammatory skin disease affecting approximately 204 million people globally, with an adult prevalence rate of about 10.6% in China [2] - The incidence of AD has been increasing annually, with nearly 30% of patients classified as moderate to severe, totaling over 67 million individuals in 2020 [2] - The number of moderate to severe AD patients in China is expected to exceed 75 million by 2025, with the disease potentially lasting for decades in adults [2]

Core Viewpoint - Ganli Pharmaceutical has received approval from the National Medical Products Administration for its investigational drug GLR1044 injection, a biosimilar to Dupixent (dupilumab), aimed at treating moderate to severe atopic dermatitis in adults [1] Group 1 - Ganli Pharmaceutical's wholly-owned subsidiary in Shandong has been granted a clinical trial approval notice for GLR1044 injection [1] - GLR1044 injection is intended for patients with inadequate control or for whom topical prescription medications are not recommended [1] - As of September 30, 2025, Ganli Pharmaceutical has invested a total of 65.7245 million RMB in the GLR1044 project [1]

Core Viewpoint - Ganli Pharmaceutical has received approval from the National Medical Products Administration for its investigational drug GLR1044 injection, which is a biosimilar to Dupilumab, aimed at treating moderate to severe atopic dermatitis in adults [1] Group 1: Drug Approval - The National Medical Products Administration issued a clinical trial approval notice for GLR1044 injection, with acceptance number CXSL2500849 and notice number 2025LP03316 [1] - GLR1044 injection meets the registration requirements for drugs and is authorized to commence clinical trials [1] Group 2: Drug Indication - The drug is indicated for the treatment of moderate to severe atopic dermatitis in adults who have inadequate control with topical prescription medications or for whom topical prescription medications are not recommended [1] - GLR1044 can be used alone or in combination with topical corticosteroids [1]

Core Viewpoint - Ganli Pharmaceutical announced that its wholly-owned subsidiary, Ganli Pharmaceutical Shandong Co., Ltd., received the clinical trial approval notice from the National Medical Products Administration for the investigational drug GLR1044 injection, which is intended for the treatment of moderate to severe atopic dermatitis in adults [1] Group 1: Product Development - The product GLR1044 is a biosimilar to Dupilumab [1] - As of September 30, 2025, the company has invested a total of 65.7245 million yuan in research and development for this project [1] Group 2: Market Context - Currently, only the original manufacturer Sanofi's Dupilumab injection has been approved for market release in China [1] - The global sales of Dupilumab are projected to be 13.072 billion euros for the fiscal year 2024 [1]

Market Overview - The biopharmaceutical sector experienced a decline of 1.72% on December 2, with Aopumai leading the drop [1] - The Shanghai Composite Index closed at 3897.71, down 0.42%, while the Shenzhen Component Index closed at 13056.7, down 0.68% [1] Individual Stock Performance - Dongbao Bio (300239) closed at 5.80, up 1.05% with a trading volume of 93,700 shares and a transaction value of 53.99 million yuan [1] - Aopumai (688293) saw a significant drop of 8.01%, closing at 50.32 with a trading volume of 33,400 shares and a transaction value of 171 million yuan [2] - Other notable declines included Kanghong Pharmaceutical (002773) down 3.78% and Watson Bio (300142) down 3.17% [2] Capital Flow Analysis - The biopharmaceutical sector experienced a net outflow of 456 million yuan from institutional investors, while retail investors saw a net inflow of 270 million yuan [2] - Notable stocks with significant capital inflows included He Yuan Bio (688765) with a net inflow of 17.69 million yuan from institutional investors [3] - Conversely, stocks like Rongchang Bio (688331) and Shenzhou Cell (688520) also saw mixed capital flows, indicating varied investor sentiment [3]

Core Insights - Indian pharmaceutical companies have made significant inroads into the Chinese market, winning multiple bids in the latest national drug procurement round, with prices drastically lower than original branded drugs, indicating a new competitive phase in the market [1][2] - The entry of Indian generics is seen as a major challenge for domestic Chinese generic drug manufacturers, who face both internal and external pressures [1][2] Group 1: Indian Pharmaceutical Companies' Market Entry - Indian companies like Hetero Labs, Cipla, Annora Pharma, and Natco Pharma have collectively won bids for seven drug varieties, marking a record for Indian firms in China's national procurement [1] - Hetero Labs' bid price of 0.215 yuan per tablet is significantly lower than AstraZeneca's original drug price of 4.36 yuan, showcasing the competitive pricing strategy of Indian generics [1] - Indian pharmaceutical firms have prepared extensively for the Chinese market, with many holding multiple registration certificates and having passed consistency evaluations for generics [2] Group 2: Competitive Advantages of Indian Generics - Indian companies benefit from lower production costs, with labor costs being 1/2 to 1/3 of those in China, and significantly lower costs for bioequivalence testing [2] - The production capacity utilization of Indian firms is around 50%, allowing them to offer competitive pricing due to excess capacity [2] - India has become the largest exporter of generics globally, supplying 20% of the world's generics and meeting 40% of the U.S. demand for generics [3] Group 3: Challenges for Chinese Generic Drug Companies - Despite having a large number of pharmaceutical companies, China struggles with quality issues, with many generics failing to meet the efficacy of original drugs [5] - Chinese generic drug companies face significant challenges from price pressures due to national procurement policies and the potential market entry of Indian generics [6] - Companies like Huahai Pharmaceutical and Kelun Pharmaceutical are already experiencing revenue declines and margin pressures due to these competitive dynamics [6] Group 4: Strategies for Chinese Pharmaceutical Companies - Chinese firms are encouraged to enhance R&D investments, focusing on complex formulations and first-generic drugs to differentiate themselves [7] - Expanding into international markets is another strategy, with companies like Ganli Pharmaceutical successfully securing large contracts in Brazil [7] - Smaller companies are advised to specialize in niche areas such as rare diseases and high-tech generics to avoid direct competition with Indian firms [7] Conclusion - The competition in the pharmaceutical market is shifting from national origin to quality, with Indian generics leveraging their scale and cost advantages [8] - The ongoing competition may lead to significant transformations within the industry, with some companies thriving while others may exit the market [8]

Core Viewpoint - Ganli Pharmaceutical has initiated China's first Phase III clinical study for a monthly formulation of glucagon-like peptide-1 receptor agonist (GLP-1RA) called Bofanglutide, aimed at weight management, which is expected to significantly improve patient adherence to medication [1][2] Group 1: Clinical Research - The GRADUAL-3 study is a randomized controlled trial designed to evaluate the efficacy and safety of Bofanglutide administered via subcutaneous injection once a month for weight loss [1] - This study is part of a larger GRADUAL series, which includes three Phase III clinical trials in China, targeting over 1,000 adult participants who are overweight or obese [2] - The primary endpoint of the GRADUAL-3 study is the change in body weight from baseline after 24 weeks of treatment [1] Group 2: Product Advantages - Compared to existing weekly GLP-1RA formulations, the monthly injection regimen of Bofanglutide reduces the number of injections from 52 to 12 per year, decreasing injection frequency by nearly 80% [1] - This reduction in injection frequency is expected to alleviate the treatment burden and enhance the quality of life for patients, addressing a critical clinical pain point in long-term weight management [1] Group 3: Broader Innovation Strategy - Ganli Pharmaceutical's innovation in metabolic diseases extends beyond GLP-1RA, with multiple new drugs entering global development, including a fourth-generation insulin (GZR) that has reached Phase III clinical trials [2] - The GZR weekly formulation is anticipated to reduce insulin injection frequency by over 85% compared to daily formulations, significantly lowering the treatment burden for diabetes patients [2] - The company is also developing a fixed-ratio combination formulation of Bofanglutide and GZR, currently in Phase II clinical trials, reflecting its strategic vision to expand from diabetes treatment to comprehensive metabolic health management [2]

Core Insights - Gan & Lee Pharmaceuticals has initiated the GRADUAL-3 phase 3 clinical study for its GLP-1 receptor agonist, bofanglutide, targeting adults with obesity or overweight [1][3] - The study aims to evaluate the efficacy and safety of once-monthly bofanglutide injection over a 24-week period [2][7] - Previous studies, GRADUAL-1 and GRADUAL-2, have established the groundwork for assessing bofanglutide's effectiveness in weight management [3][7] Study Design and Objectives - GRADUAL-3 is designed to explore the potential of bofanglutide to maintain weight loss and improve long-term adherence by administering the injection subcutaneously once every four weeks [1][4] - The primary endpoints of the study include changes in body weight and percentage change from baseline at Week 24 [2][7] - The study is part of a broader GRADUAL clinical development program, which includes three large-scale phase 3 studies with over 1,000 participants planned for enrollment [4] Previous Clinical Studies - GRADUAL-1 involved approximately 630 Chinese adults and assessed the weight-loss efficacy and safety of bofanglutide over 52 weeks [7] - GRADUAL-2 included around 471 participants and compared bofanglutide with semaglutide (Wegovy) in a head-to-head study [3][7] - Both previous studies aimed to confirm the efficacy and safety of bofanglutide in managing obesity and its impact on metabolic parameters [3][5] Product Overview - Bofanglutide (research code: GZR18) is a novel GLP-1 RA developed by Gan & Lee, focusing on obesity/overweight and type 2 diabetes indications [5] - Clinical studies have shown that bofanglutide provides significant weight-loss and glucose-lowering effects, with a safety profile consistent with existing GLP-1 RAs [5]

Core Points - As of September 30, 2025, the number of shareholders for Ganli Pharmaceutical (603087) is reported to be 94,714 [1]

Core Viewpoint - The company acknowledges the feedback from the capital market and understands investors' concerns regarding its long-term value, emphasizing that short-term stock price fluctuations do not fully reflect its operational quality and growth potential [1] Group 1: Company Strategy - The company plans to enhance its independent research and development capabilities and international expansion efforts [1] - It aims to strengthen its research and development across the entire field of diabetes diagnosis and treatment while also exploring other research pipelines [1] - The company is focused on continuously increasing its intrinsic value [1]